Patients with bronchial asthma need to be carefully monitored during therapy. Caution should be taken in the treatment of patients receiving antihistamines (see Interactions).
Effects on Fertility: Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Carcinogenicity/Mutagenicity: No animal data is available on the carcinogenic or mutagenic potential of betahistine.
Effect on Ability to Drive and Use Machines: Betahistine is presumed to be safe or unlikely to produce an effect on the ability to drive or use machinery.
Use in Pregnancy: Category B2: Betahistine hydrochloride should not be used during pregnancy (see Contraindications) since there is insufficient data on the use of this drug during pregnancy to evaluate possible harmful effects. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
Use in Lactation: Betahistine hydrochloride should not be used during lactation (see Contraindications).
Use in Children: Due to lack of clinical experience, betahistine hydrochloride should not be used in children less than 18 years (see Contraindications).
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